Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0)

Status Completed

Clinical Trial Summary

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Clinical Trial Description

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04144738
Study type	Observational
Source	Exact Sciences Corporation
Contact
Status	Completed
Phase
Start date	November 15, 2019
Completion date	March 30, 2023

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Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms